HEMOGLOBIN SCREENING DEVICE— 510(k) K882101

Name: FDA 510(k) clearance K882101
Creator: U.S. Food and Drug Administration
Published: 1988-07-01

Substantially Equivalent

Portable Medical Laboratories, Inc.

FDA 510(k) clearance K882101 for HEMOGLOBIN SCREENING DEVICE, Substantially Equivalent on 1988-07-01. Applicant: Portable Medical Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Portable Medical Laboratories, Inc.
Product code: Code KSL
Device class: Class 1
Regulation: 21 CFR 864.9320
Advisory panel: Hematology
Date received: 1988-05-11
Decision date: 1988-07-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Solana Beach, CA, US

Download summary PDF View on FDA.gov ↗

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